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Ultrasound Infection PreventionRisks, Challenges and Solutions

APIC Greater Atlanta Chapter MeetingApril 17, 2019

Ruth M. Carrico, DNP, PhD, FNP-C, FSHEA, CICAssociate Professor, Division of Infectious Diseases

University of Louisville School of Medicine

Disclosures

Support for the development and delivery of this presentation was provided by Nanosonics, Ltd.

Learning objectives

• Review recent research documenting infection risk from ultrasound procedures.

• Determine the reprocessing requirements for ultrasound probes, used in a variety of procedures, by applying the Spaulding classification, CDC and FDA guidelines.

• Discuss the significance of available evidence demonstrating the high frequency of contact between the ultrasound probe and sterile puncture site in a variety of percutaneous interventions.

• Explain the application of the ultrasound IP Toolkit components (‘Locate and Profile’, ‘Algorithm’, ‘Risk Assessment’ and ‘Policy’ tools) to ensuring that patients are safe from infection risk.

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What is ultrasound?• Ultrasound probes are heat sensitive reusable medical devices used to visualise the

anatomy in a variety of procedures.

• Ultrasound probes can require LLD, HLD or sterilization depending on the patient contact site. The same probe may require LLD for one procedure, then HLD for another procedure.

• Ultrasound probes come in a variety of shapes and sizes for a variety of procedures

External / Surface Probes

e.g. Doppler, linear, curvilinear, intraoperative probes

Endocavitary Probes

e.g. transvaginal, transrectal, transesophageal probes

Risk from ultrasound procedures2017, USA. Joint Commission. 74% of all immediate threats to life were from improper sterilization or HLD of devices

2018, USA. Facilities being cited for improper ultrasound probe reprocessing.

Updated on Oct 31, 2018 11:29 pm: https://www.wtae.com/article/more-than-200-upmc-jameson-patients-notified-about-potential-exposure-from-ultrasound-probes-used-in-exams/24498056

The Joint Commission (TJC). Improperly sterilized or HLD equipment – a growing problem. 2017. Available at: https://www.jointcommission.org/assets/1/23/qs_33a_2017.pdf

2012, UK. Patient death from hepatitis B infection thought to have been transmitted via endocavitary ultrasound

Probe was not properly disinfected.

MHRA (similar to FDA) released an alert to review all ultrasound disinfection practices in UK.

Medicines and Healthcare products Regulatory Agency (UK). Medical Device Alert: Reusable transoesophageal echocardiography, transvaginal and transrectal ultrasound probes (transducers) (MDA/2012/037). 2012.

Risk from ultrasound procedures

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2018, Scotland. Study demonstrated epidemiological link between improper endocavitary probe disinfection with LLD and increased infection risk.

Scott D et al. Ultrasound. 2018 Aug;26(3):168-177.

• 30 days after a TV scan (results highly significant): • Patient is 41% m ore likely to have positive bacterial cultures

• Patient is 26% m ore likely to be prescribed antibiotics

• 30 days after a TR scan (results highly significant):• Patient is 3.40x m ore likely to have positive bacterial cultures• Patient is 75% m ore likely to be prescribed antibiotics

• 30 days after a TOE scan:• Patient is 4.92x m ore likely to have positive bacterial cultures (result

highly significant)• Patient is 5% m ore likely to be prescribed antibiotics (not significant)

Risk from ultrasound procedures

1. Shaban RZ, et al. American journal of infection control. 2017;45(9):954-58.2. Abdelfattah R, et al. Journal of Hospital Infection. 2018;98(3):289-94.3. Cheng A, et al. Clinical Microbiology and Infection. 2016;22(4):382. e1-e11.

2016-2018. Outbreaks have occurred in external ultrasound probe guided procedures, linked to contaminated ultrasound gel.

Multiple patients effected across many facilities, following ultrasound guided CVC insertion, nerve blocks, arthrocentesis, amniocentesis, among many more.1-3

Risk from ultrasound procedures

Overview of ultrasound probe reprocessing

CleaningA process which involves physical removal of soil

from the surfaces of devices to prepare the items for

safe handling and/or further decontamination.

StorageA process that prevents

recontamination ofreprocessed devices,

ensuring they areavailable for reuse.

DisinfectionProcess by which

pathogenic microorganisms aredestroyed in order

to prevent patient topatient transmission.

TraceabilityThe ability to verify the history, location, or application of an item by means of documented recorded identification.

Semi-critical and critical probes must be traced.

Next patient use

CDC 2008 – Guideline for Disinfection and Sterilization in Healthcare Facilities.AAMI ST58:2013 - Chemical sterilization and high-level disinfection in health care facilities.

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Spaulding classificationDisinfection Level Required

Low Level Disinfection

High Level Disinfection

SterilizationCRITICAL

SEMI-CRITICAL

NON-CRITICAL

Device only contacts intact, healthy skin

Device contacts mucous membranes or non-intact skin

Device enters or contacts sterile tissue or the

bloodstream

Most vegetative bacteria

All viable microorganismsmust be destroyed.

All viable microorganismsmust be destroyed,

except bacterial spores.

and viruses destroyed, except bacterial spores,

mycobacteria, fungi, or small non-lipid viruses.

Device Classification

CDC & FDA: Sheaths don’t replace reprocessing

‘Do not use a lower category of disinfection or cease to follow the appropriate disinfectant recommendations when using probe covers because these sheaths and condoms can fail.’ (pg. 89)

CDC 2008. Guideline for Disinfection and Sterilization in Healthcare Facilities

‘For clinical applications of a semi-critical or critical nature (e.g., intraoperative, transrectal, transvaginal, transesophageal, or biopsy procedures), labeling should recommend, when appropriate, the use of sterile, legally marketed probe sheaths. Note that the use of sheaths does not change the type of reprocessing that is recommended after each use.’ (pg. 17)

‘The probe used in a semi-critical application should be cleaned and sterilized or at least receive high level disinfection after use even if a sheath was used. Probes used for critical applications should be cleaned and sterilized after use even if a sterile sheath was used. Sheaths can fail during use and the level of resulting contamination may not be easily visible.’ (pg. 57)

FDA 2008. Inform ation for M anufacturers Seeking M arketing Clearance of Diagnostic

Ultrasound System s and Transducers.

Ultrasound is complex

Complex to manage

People Places Procedures• Doctors• Nurse Practitioners• Physician Assistants• Students• Technicians• Sonographers• Radiologists

• OBGYN/MFM• Interventional radiology• Emergency• Cardiology• Surgery• Anesthesiology• Gastroenterology

• Transvaginal scans• Transrectal scans• External surface scans• Intraoperative scans• Biopsies• Drainages• Aspirations

• Physical Therapists• Allied Health

• Musculoskeletal• Nephrology

• etc….

• Injections• Cannulations

• etc…. • etc….

Probes are widely used in invasive procedures and can involve contact with sterile tissue or mucous membranes

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Varied practices in ultrasound reprocessing across healthcare

2018, USA. Survey finds ultrasound use is far more widespread than expected.

Ultrasound is used in almost every healthcare department.

Variability in ultrasound probe disinfection practices for the same procedure across the nation.

How do we begin to standardize probe reprocessing policy and practice rationally?

Carrico et al. American Journal of Infection Control 46 (2018) 913-20.

External Ultrasound Probe Reprocessing

Low

High

Extreme

Complexity

External probe reprocessing is more complex than endocavitary probe reprocessing

Intracavity External

Spaulding classification based on use

Number of departments

Variety of procedures

Individuals performing scans

Individuals performing reprocessing

Number of reprocessing locations

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Example procedures with external ultrasound probes

target

probe

needle skin

Percutaneous intervention eg biopsy

probe

non intact skin

Scan across unhealthy skineg epidermal cyst scan

probe

healthy skin

Scan across healthy skineg routine pregnancy

Increasing risk of infection

sterile tissue

The Spaulding Classification

1. Rutala WA, Weber DJ, HICPAC, CDC. Guideline for Disinfection and Sterilization in Healthcare Facilities. 2008.

2. FDA 2000. Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants.

3. FDA 2008. Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers. 4. FDA 2015. Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.

5. AORN. Guidelines for Perioperative Practice

6. ST58:2013 Chemical sterilization and high-level disinfection in health care facilities.“7. CMS IC Worksheet: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-15-12-Attachment-1.pdf

8. TJC IC Standards (login): https://e-dition.jcrinc.com/MainContent.aspx

9. Spaulding EH. Chemical disinfection of medical and surgical materials. In:Lawrence C, Block SS, editors. Disinfection, sterilization, and preservation. Philadelphia (PA): Lea & Febiger; 1968. p. 517-31.

• CDC, FDA, AORN guidelines and AAMI standards use this framework to define requirements for device disinfection and sterilization in healthcare settings.1-6

• Healthcare facilities must correctly apply this framework for accreditation (covered in CMS infection control worksheet and TJC standards).7,8

• It is a rational approach to disinfection and sterilization of resuable devices based on risk1,9

• Framework is so clear and logical that it has been successfully used since its inception in 1968 by reprocessing experts to determine the appropriate level of disinfection or sterilization.1

CRITICAL

SEMI-CRITICAL

NON-CRITICAL

Device only contacts intact, healthy skin

Device contacts mucous membranes or non-intact skin

Device enters or contacts sterile tissue or the

bloodstream

Spaulding EH (1968). Chemical disinfection of medical and surgical materials. Disinfection, sterilization, and preservation. Lawrence C, Block SS. Philadelphia (PA), Lea & Febiger: 517-531.

“The first category is that of critical items, so called because the risk is great. They are either introduced beneath the surface of the body or attached to another object which is, i.e., transfer forceps, scalpel blades, cardiac catheters and plastic components of the heart-lung oxygenator.”

“The third category consists of noncritical items which do not make contact with the patient or, if they do, only with unbroken skin.”

“Materials in the second category are semicriticalitems…They make direct contact with mucous membranes, but these tissues are intact and therefore constitute barriers to infection.”

The Spaulding Classification

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Disinfection Level Required

Low Level Disinfection

High Level

Disinfection

Sterilization

CRITICAL

SEMI-CRITICAL

NON-CRITICAL

Device only contacts

intact, healthy skin

Device contacts mucous

membranes or non-intact skin

Device enters or contacts

sterile tissue or the

bloodstream

Most vegetative bacteria

All viable microorganismsmust be destroyed.

All viable microorganismsmust be destroyed,

except bacterial spores.

and viruses destroyed, except bacterial spores,

mycobacteria, fungi, or small non-lipid viruses.

Device Classification

1 . C D C 2 0 0 8 . G u id e lin e fo r D isin fe ctio n an d Ste rilizatio n in H e alth care Fac ilit ie s.

2 . Sp au ld in g EH . C h e m ica l d isin fe ctio n o f m e d ica l an d su rg ica l m ate ria ls. In :Law re n ce C , B lo ck SS , e d ito rs. D isin fe ctio n , ste rilizatio n , an d p re se rvatio n . Ph ilad e lp h ia (PA ): Le a & Fe b ige r; 1 9 6 8 . p . 5 1 7 -3 1 .

The Spaulding Classification

CDC: minimum HLD for probes used in surgery

CDC 2008. Guideline for Disinfection and Sterilization in Healthcare Facilities

Ultrasound probes used during surgical procedures also can contact sterile body sites. These probes can be covered with a sterile sheath to reduce the level of contamination on the probe and reduce the risk for infection. However, because the sheath does not completely protect the probe, the probes should be sterilized between each patient use as with other critical items. If this is not possible, at a minimum the probe should be high-level disinfected and covered with a sterile probe cover.’ (pg. 19)

FDA reprocessing recommendations for probes used in surgery and in biopsies

‘For clinical applications of a semi-critical or critical nature (e.g., intraoperative, transrectal, transvaginal, transesophageal, or biopsy procedures), labeling should recommend, when appropriate, the use of sterile, legally marketed probe sheaths. Note that the use of sheaths does not change the type of reprocessing that is recommended after each use.’ (pg. 17)

FDA 2008. Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.

‘The probe used in a semi-critical application should be cleaned and sterilized or at least receive high level disinfection after use even if a sheath was used. Probes used for critical applications should be cleaned and sterilized after use even if a sterile sheath was used. Sheaths can fail during use and the level of resulting contamination may not be easily visible.’ (pg. 57)

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• American Institute of Ultrasound in Medicine (AIUM) changed their guidelines in March 2018 from HLD to LLD for percutaneous intervention

• Contradicts FDA, CDC and Spaulding

• AIUM includes a caveat – “If there is reason to believe that the probe cover may become compromised, the probe must be high-level disinfected prior to the procedure”

• A survey found that 25.4% of interventional radiologists had experienced a needle stick injury in the past year; 75.5% of cases were attributed to operator error1

Other guidelines

1. Reddy P et al. J Vasc Interv Radiol. 2009;20(8):1070-4 e5.

Application of FDA, CDC and Spaulding to other procedures

target

probe

needle skin

Biopsy probe requiresminimum HLD

with use of sterile sheath according to FDA & CDC

Nerve block

‘centesis’

Injection

target

needle skin

needle

needle

Following Spaulding’s rationale, if the probe contacts sterile tissue, then these probes are critical devices.

probe

probe

skin

skin

target

target

sterile tissue probe

‘Virtual Observation’ analysis study• Purpose of this study was to investigate whether contact with puncture site

occurred in routine procedures

• Video stills were analysed from educational YouTube content. The first 100 videos from each procedure search were analysed with selection criteria applied (e.g. probe and needle need to be clearly visible and performed on a real patient).

• Following Spaulding’s rationale, if the probe contacts sterile tissue, then these probes are critical use devices. If probe contacts broken sin, probes are semi critical use devices.

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Methods – Category definition and assignmentCategory A Category B Category C

Clear contact between probe and needle

puncture

Probe and needle in very close proximity

(< 10 mm)

Probe and needle not in very close proximity

(> 10 mm)

Results – High risk of contact between probe and puncture in 90% of procedures

Results – Examples of clear contact (Category A)

Internal jugular vein central venous catheter insertion

Central venous catheter insertion

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Liver abcess drainage Pericardiocentesis

Results – Examples of clear contact (Category A)

Interscalene block Thoracentesis

Results – Examples of clear contact (Category A)

Takeaways from virtual observation

• Analysis shows regular contact between needle and probe

• Important for facilities to review and observe their use of ultrasound to guide procedures and apply Spaulding

• When developing policies, prioritize evidence based guidelines and standards promulgated by standards development agencies recognized by TJC and CMS.

• Where risks to the patient exist, reviews and risk assessments should be conducted to maximise patient safety.

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Practicalities of implementation in vascular access• There are some procedures where routine HLD of probes used in percutaneous

interventions would be more difficult• Example: mobile vascular teams – there is currently no practicable solution for

mobile HLD• Institutions should review what they should do for these procedures• AVA guidelines recommend LLD + sheath, however include a caveat that

recommends HLD:“14. In the event ongoing process monitoring identifies cleaning and disinfectant failure(s), adverse patient outcomes that may be attributable to transducer reprocessing methods, oruser techniques that demonstrate risk to the use of Low Level Disinfection (e.g., needlestickinjuries, damage to transducer/probes, punctures of sheaths during procedures) existing approaches should be re-evaluated with consideration of operational and organizational changes including centralization of cleaning and disinfection, use HLD, or other changes that serve to protect the safety of the patient. “

AVA 2018. Transducer Disinfection for Assessment and Insertion of Peripheral and Central Catheters for Vascular Access Teams and Clinicians.

Practicalities of implementation

• This is a complex issue that needs collaboration between IPs, reprocessing experts, risk management experts, quality experts, patient safety experts,department heads and staff.

• Working together to discuss, observe procedures and review or write policy takes time.

• A group of experts has developed some tools to help IPs initiate these processes to work toward the common goal of patient safety.

Solutions

www.ultrasoundinfectionprevention.org

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• Four free practical tools designed by a group of concerned IPs and device reprocessing experts to help users meet existing evidence-based guidelines and standards.

• Editable to comply with institutional, local, state and regional policies/guidelines.

Contributors

Sue Barnes RN CIC FAPIC

Roy Boukidjian MSN PHN CIC

Ruth Carrico PhD DNP APRN FSHEA CIC

Robert Garcia BS MMT CIC

Sylvia Garcia-Houchins RN MBA CICAmy Nichols RN MBA CICRose Seavey RN CIC FAPICJohn Whelan BSN RN

Introducing the Ultrasound IP Toolkit

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Instructional video by Amy Nichols RN MBA CIC presented at APIC 2018 National Conference

www.ultrasoundinfectionprevention.org

Accessing the toolkit

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Download all 4 tools as a zip file

Accessing the toolkit

Option to sign up for updates as more tools are posted

Download tools individually

www.ultrasoundinfectionprevention.org

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Tool 1 – First locate ultrasound machines

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• Example strategies are listed

• Ordered by assumed effectiveness

• All can be used in combination to locate all your machines

Strategy Rationale H ow Lim ita tions

1. L o cate w h ere u ltraso u n d m ach in es are b y

search in g th e o rg an izatio n ’s

asset reg ister.

C lin ical/B io m ed ical E n g in eerin g d ep artm en t m ain tain s an asset reg ister o f eq u ip m en t u sed

th ro u g h o u t th e facility . T h e asset reg ister lin k s th e u ltraso u n d

m ach in e an d asso ciated serv ice co n tracts to d ep artm en t lo catio n s.

A sk th e C lin ical/B io m ed ical E n g in eerin g d ep artm en t to p ro v id e a co m p lete list o f u ltraso u n d p ro b es an d co n so les fro m

th eir asset reg ister. Id en tify th e d ep artm en t in w h ich th ey are lo cated .

• N o t a ll u ltraso u n d m ach in es m ay b e listed o n th e reg ister.

• A sset reg isters m ay b e in co m p lete (e .g .,

d u e to m erg ers/acq u isitio n s, p u rch ases b e in g m ad e b y lo cal d ep artm en ts, tria l

eq u ip m en t is b e in g u sed o r o th er reaso n s).

2 . L o cate w h ere u ltraso u n d co n su m ab les are

b e in g u sed (e .g ., g e l, p ro b e

sh eath s/co vers).

A ll u ltraso u n d p ro b es are u sed w ith u ltraso u n d g e l w h ich is essen tia l fo r im ag in g q u ality . S o m e

u ltraso u n d p ro b es are u sed w ith sh eath s/co vers. L o catin g

u ltraso u n d g e l an d p ro b es co vers w ill lead to th e d ep artm en ts u sin g

u ltraso u n d p ro b es.

A p p ro ach m ateria ls m an ag em en t, p u rch asin g o r su p p ly ch ain m an ag em en t an d req u est th ey search p u rch ase o rd ers

an d in ven to ry lists fo r each d ep artm en t/th e facility , an d p ro vid e a

rep o rt o f m ateria l.

• It m ay b e d ifficu lt to o b tain p u rch ase o rd ers an d in ven to ry, p articu larly if a cen tral system is n o t in p lace .

• S o m e co n su m ab les m ay b e o rd ered cen trally an d d istrib u ted o r m ay b e

o rd ered an d p u rch ased lo cally (e .g ., b y in d iv id u al d ep artm en ts o r u n its).

3 . S u rvey d ep artm en ts to id en tify w h ere

u ltraso u n d is u sed .

E n d u sers are th e b est p laced to k n o w w h ere u ltraso u n d is b e in g u sed .

A p p ro ach d ep artm en ts an d ask ab o u t th e ir u ltraso u n d u se . M eth o d s in clu d e b u t are n o t lim ited to : d ep artm en tal/ facility

w id e em ail, p h ysically v is itin g o r p h o n in g each d ep artm en t an d /o r p atien t care u n it

lead ersh ip .

• It m ay b e tim e co n su m in g to reach a ll d ep artm en ts.

• It m ay b e d ifficu lt to id en tify staff w ith fu ll

k n o w led g e o f u ltraso u n d u se in th e ir d ep artm en t.

4 . Id en tify b illab le u ltraso u n d

p ro ced u res in fin an cia l

reco rd s.

U ltraso u n d p ro ced u res sh o u ld b e b illed . If u ltraso u n d p ro ced u re item co d es are o b tain ed , th ey can

th en b e u sed to id en tify w h ich d ep artm en ts o r p ro v id ers are

b illin g fo r th o se item s.

Id en tify u ltraso n o g rap h y b illin g co d es; ask fin an ce d ep artm en t fo r a list o f b illin g reco rd s th at in vo lve u ltraso u n d p ro ced u re

item co d es an d d eterm in e w h ich d ep artm en ts are b illin g fo r th o se item s.

• B illin g m ay n o t p ro v id e d ep artm en t sp ecific in fo rm atio n .

• T h e fin an ce system m ay n o t b e setu p to

read ily p erfo rm th ese search es.• It m ay b e d ifficu lt to d eterm in e w h ich item

co d es are asso ciated w ith u ltraso u n d p ro ced u res o r p ro b es.

Tool 1 – Profile procedure policy and practice

• Checklist guides user through reviewing policy and procedures

• Visit department and read policy

• Record how policy directs user to disinfect and use probe

• Determine if policy complies with guidelines (see Tool 2)

• Observe how users reprocess and use probe in practice

• If shaded boxes selected, action plan required due to discrepancies between policy, practice and guidelines

Tool 1 – Profile procedure policy and practice

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Tool 2 - Algorithm

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• Organized by department

• Provides a range of typical procedures for that department.

• Probe use and reprocessing requirements are presented as a decision making algorithm based on CDC, FDA guidelines and AAMI standards.

Use this tool:• As a printed quick reference guide in the department’s

procedure room• To guide assessment of practice/policy in Tool 1• With Tool 4 – Policy Development Framework, to help build

your facility/department policy

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Available for the following departments:

1. Anesthesiology2. Emergency3. Cardiology4. Gastroenterology

5. Musculoskeletal 6. Nephrology7. Neurology8. OB/GYN/MFM9. Oncology10. Pulmonology11. Radiology and Interventional Radiology12. Urology13. Vascular

Tool 2 - Algorithm

Tool 3 – Example risk assessment

• Designed to assess potential hazards that may be encountered during the use and reprocessing of ultrasound probes

• Use to assess safety of existing processes and processes under consideration

• Consider new products/processes if mitigations cannot be reduced to low

• Not all rows in example may be relevant to your specific situation – those rows can be deleted and other rows can be added

• 4 templates: cleaning, disinfection, storage and use

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• An example risk matrix is provided• Facility may have standard risk matrix which can be used

Likelihood = the chance that the hazard will occur and result in harm

Severity = seriousness of harm

Likelihood x Severity = Risk

Tool 3 – Example risk assessment

Does thishazard and

harm apply?

Rate likelihood, severity and risk

Can mitigation be applied or low risk after mitigation?

If mitigations cannot be applied to ensure

low risk rating, consider new processes or

products

Tool 3 – Example risk assessment

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• This tool provides the framework to help develop an ultrasound infection prevention policy

• Comprehensive document covering all aspects of probe reprocessing, probe use and staff training.

• Completely editable document to address different departments and facilities.

• Developed based on major evidence based guidelines, standards and scientific literature.

Tool 4 – Policy development framework

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Referenced

Blue instructional boxes to help you edit and customize for your facility or department

Tool 4 – Policy development framework

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Provides background info on ultrasound reprocessing topic

Figures and tables summarizing considerations

Tool 4 – Policy development framework

• There is risk from ultrasound procedures

• Risk is compounded by the complexity of ultrasound – variety of departments, procedures and end users

• Follow federal guidelines and national standards and apply the Spaulding classification to standardize your disinfection practices

• Download and use the toolkit to help assess, evaluate and create your facility policy

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Summary

www.ultrasoundinfectionprevention.org

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Ultrasound Infection PreventionRisks, Challenges and Solutions

Thank you, Questions?